If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:
BSI's standards specify minimum requirements and test methods for ophthalmic instruments, ophthalmoscopes and opthalmic implants.
This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards, i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.
